Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis

2011 ◽  
Vol 32 (2) ◽  
pp. 159-167 ◽  
Author(s):  
Eli O. Meltzer ◽  
Tulin Shekar ◽  
Ariel A. Teper
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Mometasone Furoate

Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis

2019 ◽  
Vol 40 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Eduardo Urdaneta ◽  
Kaan Tunceli ◽  
Davis Gates
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Mometasone Furoate ◽  
Double Blind ◽  
Positive Skin ◽  
Once Daily ◽  
Responder Analysis ◽  
End Point

Background: Nasal congestion is consistently identified as the most bothersome symptom of seasonal allergic rhinitis (SAR), and, in guidelines, intranasal corticosteroids are the preferred treatment for nasal congestion. Objective: The aim of this post hoc cumulative responder analysis was to examine the nasal congestion response in detail by depicting the level of response obtained in two double-blind, placebo controlled studies of mometasone furoate nasal spray (MFNS) therapy for SAR, conducted from August to October 2008 at U.S. sites, in which nasal congestion was prespecified as the primary end point. Methods: Patients ≥12 years of age with a ≥2-year SAR history, positive skin test result, and moderate or severe nasal congestion were randomly assigned to once-daily treatment in the morning with MFNS or placebo for 15 days. The primary end point was the change from baseline in morning and evening reflective nasal congestion scores averaged over days 1‐15. Treatment response, which ranged from >0% to >90% improvement, was evaluated at 10% intervals; >30% and >50% improvements were further evaluated by using the Mietinnen-Nurminen method weighted by study to test the differences of proportions. The Breslow-Day equal odds ratios test was used to justify pooling. Results: Of the 344 and 340 patients in the MFNS and placebo groups, respectively, the proportions of patients who experienced a >30% response in nasal congestion, averaged over 15 days, were 37% versus 19% in the MFNS and placebo groups, respectively (p < 0.001). Those who experienced a >50% response were 13% and 7%, respectively (p = 0.003). Among the patients treated with MFNS, the mean response was greater during the second versus the first week of treatment. There was no difference between responses in the morning versus evening or for patients with moderate versus severe nasal congestion at baseline. Conclusion: MFNS is effective in relieving moderate-to-severe nasal congestion in patients with SAR. The response to MFNS is maintained with once-daily administration and improves with continuous use over 2 weeks.

Onset of action of mometasone furoate nasal spray (NASONEX® ) in seasonal allergic rhinitis

Allergy ◽  
1999 ◽  
Vol 54 (1) ◽  
pp. 64-69 ◽  
Author(s):  
Rb Berkowitz ◽  
Di Bernstein ◽  
C LaForce ◽  
Aj Pedinoff ◽  
Ar Rooklin ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Mometasone Furoate ◽  
Onset Of Action

Double-Blind, Placebo-Controlled Trial of Reformulated Azelastine Nasal Spray in Patients with Seasonal Allergic Rhinitis

2009 ◽  
Vol 23 (5) ◽  
pp. 512-517 ◽  
Author(s):  
Jonathan A. Bernstein ◽  
Bruce Prenner ◽  
Berrylin J. Ferguson ◽  
Jay Portnoy ◽  
William J. Wheeler ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Dose Response ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Taste Masking ◽  
Comparable Efficacy ◽  
Original Formulation ◽  
Double Blind

Background Azelastine nasal spray is a topical antihistamine with a distinctive taste that may be objectionable to some patients. The primary objectives of this clinical trial were (1) to determine if a reformulated azelastine nasal spray (Astepro) with sucralose as a taste-masking agent provides comparable efficacy to the original formulation (Astelin) and (2) to evaluate dose–response relationships between groups. Methods Eight hundred thirty-five patients with seasonal allergic rhinitis were randomized to six treatment groups: (1) original azelastine nasal spray, 1 spray/nostril b.i.d.; (2) reformulated azelastine, 1 spray/nostril b.i.d.; (3) placebo, 1 spray/nostril b.i.d.; (4) original azelastine nasal spray, 2 sprays/nostril b.i.d., (5) reformulated, 2 sprays/nostril b.i.d.; and (6) placebo, 2 sprays/nostril b.i.d. The primary efficacy variable was the change from baseline to day 14 in total nasal symptom score (TNSS) consisting of runny nose, sneezing, itchy nose, and nasal congestion. Results Original azelastine nasal spray and the reformulated spray produced comparable improvements in the TNSS at both dosages. There was a dose-related difference in TNSS comparing the 1- and 2-spray dosages. The percentage changes from baseline in the TNSS in the 2-sprays/nostril dosage groups were 27.9% (p < 0.001) with the reformulated nasal spray, 23.5% (p < 0.01) with the original formulation, and 15.4% with placebo. The incidence of bitter taste was 7% with the reformulated spray and 8% with the original at the 2-sprays/nostril dosage. Conclusion The results of this study showed efficacy both with original azelastine nasal spray and with the reformulated nasal spray and a clear dose–response difference between the 1- and 2-spray dosages.

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